Posts Tagged 'FDA recall'

Breast Pump Adapters Recalled

Playtex Manufacturing is voluntarily recalling electric breast pump AC/DC power adapters over concerns of potential electric shock, although there have been no known injuries, the FDA announced Thursday.

Read more about the breast pump recall…

Intuitive Surgical May Not Have Tested Devices Properly

Intuitive Surgical Inc. (ISRG), the maker of the da Vinci Surgical System robots, informed customers that 30 devices may not have been tested properly, according to the U.S. Food and Drug Administration. The FDA, calling it a “class 2 recall,” said the action affects Intuitive’s da Vinci Si Vision System Cart, Si Surgeon Side Cart, Instrument Control Box and Dual Camera Controller, in notices posted on its website yesterday.

Read more about the da Vinci Surgical System recall…

 

Georgia compounding pharmacy issues recalls

Until further notice, health care providers should stop using all sterile products distributed by Clinical Specialties Compounding and return them to the company, the FDA said. The FDA had previously reported the five cases of serious eye infection from injections of the cancer drug Avastin, which was prepared by Clinical Specialties Compounding Pharmacy (CSCP) to treat the eyesight robbing disease macular degeneration. The drug is not approved for that use, but when cut into doses appropriate for the eye it is substantially cheaper than similar drugs approved for the eye condition.

Read more about the macular degeneration drug recall…

Ranbaxy Declines After Recall of Generic Lipitor in U.S.

Ranbaxy Laboratories Ltd. (RBXY) fell the most in more than three months after announcing a recall of the company’s generic version of Pfizer Inc. (PFE)’s cholesterol treatment Lipitor. Ranbaxy is pulling the pills from the U.S. because they may contain small particles of glass, the company said in a statement on its website. The recall of atorvastatin will cause a “temporary disruption” in the supply of the drug and it will take two weeks to complete an investigation into the issue, Ranbaxy said.

Learn more about the generic Lipitor recall…

Two more New England Compounding Center drugs contaminated

Two more drugs made by the New England Compounding Center (NECC) are crawling with various kinds of bacteria, FDA tests reveal. The NECC is the Massachusetts compounding pharmacy whose drugs are the likely source of the ongoing outbreak of fungal meningitis.

Read more about the additional NECC contaminated drugs…

GranuFlo manufacturer memo details deaths related to drug

The manufacturer of the dialysis drug GranuFlo detailed the deaths and risks associated with the drug in an internal memo. Fresenius Medical Care (FMC) released the memo to doctors within its dialysis facilities in November 2011, but allegedly did not release it to other doctors or patients.

Read more about the Fresenius Medical Care internal memo…

GranuFlo manufacturer under investigation for failing to warn patients

The manufacturer of GranuFlo is under investigation to determine if it violated federal regulations by failing to warn patients of risks associated with the drug. The Food and Drug Administration launched the investigation against Fresenius Medical Care after it received a leaked memo from the company indicating its dialysis product GranuFlo could be lethal.

Read more about the Fresenius Medical Care investigation…


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